EP2343048A3 - Stabilized and preserved ketotifen ophthalmic compositions - Google Patents

Stabilized and preserved ketotifen ophthalmic compositions Download PDF

Info

Publication number
EP2343048A3
EP2343048A3 EP10177749A EP10177749A EP2343048A3 EP 2343048 A3 EP2343048 A3 EP 2343048A3 EP 10177749 A EP10177749 A EP 10177749A EP 10177749 A EP10177749 A EP 10177749A EP 2343048 A3 EP2343048 A3 EP 2343048A3
Authority
EP
European Patent Office
Prior art keywords
ophthalmic compositions
stabilized
hydrogen peroxide
preserved
ketotifen ophthalmic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP10177749A
Other languages
German (de)
French (fr)
Other versions
EP2343048A2 (en
EP2343048B1 (en
Inventor
Fu-Pao Tsao
Michelle P. Wong
Shau Fong Yen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novartis Pharma GmbH
Novartis AG
Original Assignee
Novartis Pharma GmbH
Novartis AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Novartis Pharma GmbH, Novartis AG filed Critical Novartis Pharma GmbH
Publication of EP2343048A2 publication Critical patent/EP2343048A2/en
Publication of EP2343048A3 publication Critical patent/EP2343048A3/en
Application granted granted Critical
Publication of EP2343048B1 publication Critical patent/EP2343048B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4535—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/14—Decongestants or antiallergics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Plural Heterocyclic Compounds (AREA)

Abstract

Ophthalmic compositions comprising ketotifen, a source of hydrogen peroxide providing an amount of hydrogen peroxide of from about 0.001 to about 0.1 % (w/v), one or more ocular-compatible hydrogen peroxide stabilizers, HPMC and CMC, and methods for the treatment and prevention of allergic conjunctivitis using these ophthalmic compositions are provided herein.
EP10177749.8A 2005-08-26 2006-08-24 Stabilized and preserved ketotifen ophthalmic compositions Active EP2343048B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/212,959 US20070048389A1 (en) 2005-08-26 2005-08-26 Stabilized and preserved ketotifen ophthalmic compositions
EP06802301.9A EP1922059B1 (en) 2005-08-26 2006-08-24 Stabilized and preserved ketotifen ophthalmic compositions

Related Parent Applications (5)

Application Number Title Priority Date Filing Date
EP06802301.9 Division 2006-08-24
EP06802301.9A Division-Into EP1922059B1 (en) 2005-08-26 2006-08-24 Stabilized and preserved ketotifen ophthalmic compositions
EP06802301.9A Division EP1922059B1 (en) 2005-08-26 2006-08-24 Stabilized and preserved ketotifen ophthalmic compositions
WOPCT/US2006/033161 Previously-Filed-Application 2006-08-24
PCT/US2006/033161 Previously-Filed-Application WO2007025092A2 (en) 2005-08-26 2006-08-24 Stabilized and preserved ketotifen ophthalmic compositions

Publications (3)

Publication Number Publication Date
EP2343048A2 EP2343048A2 (en) 2011-07-13
EP2343048A3 true EP2343048A3 (en) 2011-08-03
EP2343048B1 EP2343048B1 (en) 2016-05-04

Family

ID=37441908

Family Applications (2)

Application Number Title Priority Date Filing Date
EP06802301.9A Active EP1922059B1 (en) 2005-08-26 2006-08-24 Stabilized and preserved ketotifen ophthalmic compositions
EP10177749.8A Active EP2343048B1 (en) 2005-08-26 2006-08-24 Stabilized and preserved ketotifen ophthalmic compositions

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP06802301.9A Active EP1922059B1 (en) 2005-08-26 2006-08-24 Stabilized and preserved ketotifen ophthalmic compositions

Country Status (12)

Country Link
US (5) US20070048389A1 (en)
EP (2) EP1922059B1 (en)
JP (1) JP5111372B2 (en)
KR (1) KR20080042144A (en)
CN (1) CN101252911A (en)
AU (2) AU2006282978A1 (en)
BR (1) BRPI0615394B8 (en)
CA (1) CA2619582C (en)
ES (2) ES2585777T3 (en)
MX (1) MX2008002654A (en)
RU (1) RU2444361C2 (en)
WO (1) WO2007025092A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010107525A1 (en) * 2009-03-17 2010-09-23 Aciex Therapeutics, Inc. Ophthalmic formulations of ketotifen and methods of use
WO2022006653A1 (en) * 2020-07-09 2022-01-13 Aliya Pharmaceuticals Inc. Anti-cancer activity of perborate salts

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0354186A1 (en) * 1988-08-04 1990-02-07 Ciba-Geigy Ag A method of preserving ophthalmic solutions and compositions therefor
US20020127281A1 (en) * 2000-09-28 2002-09-12 Fu-Pao Tsao Stabilized hyrogen peroxide solutions
US20020165254A1 (en) * 1998-01-15 2002-11-07 Kis Gyorgy Lajos Autoclavable pharmaceutical compositions containing a chelating agent
WO2003059069A1 (en) * 2002-01-18 2003-07-24 Novartis Ag Methods for preserving ophthalmic solutions and preserved ophtalmic solutions

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4614646A (en) * 1984-12-24 1986-09-30 The Dow Chemical Company Stabilization of peroxide systems in the presence of alkaline earth metal ions
US5607698A (en) * 1988-08-04 1997-03-04 Ciba-Geigy Corporation Method of preserving ophthalmic solution and compositions therefor
DE4023086A1 (en) * 1990-07-20 1992-01-23 Hoechst Ag METHOD FOR TREATING ALLERGIC CONNECTIVITY
US5958957A (en) * 1996-04-19 1999-09-28 Novo Nordisk A/S Modulators of molecules with phosphotyrosine recognition units
US6265444B1 (en) * 1997-05-23 2001-07-24 Insite Vision Incorporated Ophthalmic composition
GB9824160D0 (en) * 1998-11-04 1998-12-30 Darwin Discovery Ltd Heterocyclic compounds and their therapeutic use
US6239113B1 (en) * 1999-03-31 2001-05-29 Insite Vision, Incorporated Topical treatment or prevention of ocular infections
US6777429B1 (en) * 1999-07-23 2004-08-17 Novartis Ag Ophthalmic composition
RU2266115C2 (en) * 1999-09-13 2005-12-20 Бридж Фарма, Инк. Ketothiphen optically active isomers and their therapeutically active metabolites
US6531128B1 (en) * 2000-02-08 2003-03-11 Pharmacia Corporation Methods for treating glaucoma
US6924292B2 (en) * 2000-03-23 2005-08-02 Takeda Chemical Industries, Ltd. Furoisoquinoline derivatives, process for producing the same and use thereof
RU2193403C1 (en) * 2001-05-23 2002-11-27 Московский научно-исследовательский институт глазных болезней им. Гельмгольца Ophthalmic drops for treating allergic conjunctivitis and keratoconjunctivitis
PE20030263A1 (en) * 2001-07-31 2003-04-17 Novartis Ag PHARMACEUTICAL OPHTHALMIC COMPOSITION
US20040072809A1 (en) * 2002-07-30 2004-04-15 Omeros Corporation Ophthalmologic irrigation solutions and method
US20050244509A1 (en) * 2004-03-17 2005-11-03 Fu-Pao Tsao Ophthalmic solutions
US20070048388A1 (en) * 2005-08-26 2007-03-01 Fu-Pao Tsao Stabilized and preserved ketotifen ophthalmic compositions
JP4858306B2 (en) 2006-07-27 2012-01-18 株式会社デンソー Method for manufacturing thermoelectric conversion device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0354186A1 (en) * 1988-08-04 1990-02-07 Ciba-Geigy Ag A method of preserving ophthalmic solutions and compositions therefor
US20020165254A1 (en) * 1998-01-15 2002-11-07 Kis Gyorgy Lajos Autoclavable pharmaceutical compositions containing a chelating agent
US20020127281A1 (en) * 2000-09-28 2002-09-12 Fu-Pao Tsao Stabilized hyrogen peroxide solutions
WO2003059069A1 (en) * 2002-01-18 2003-07-24 Novartis Ag Methods for preserving ophthalmic solutions and preserved ophtalmic solutions

Also Published As

Publication number Publication date
RU2008111065A (en) 2009-10-10
US20070048389A1 (en) 2007-03-01
EP1922059B1 (en) 2016-06-22
BRPI0615394B8 (en) 2021-05-25
CA2619582A1 (en) 2007-03-01
EP2343048A2 (en) 2011-07-13
CN101252911A (en) 2008-08-27
ES2592914T3 (en) 2016-12-02
EP1922059A2 (en) 2008-05-21
MX2008002654A (en) 2008-03-18
WO2007025092A3 (en) 2007-09-27
BRPI0615394A2 (en) 2011-05-17
AU2010235948A1 (en) 2010-11-11
CA2619582C (en) 2014-11-18
BRPI0615394B1 (en) 2020-05-19
AU2010235948B2 (en) 2011-09-22
US20080207692A1 (en) 2008-08-28
AU2006282978A1 (en) 2007-03-01
JP2009506064A (en) 2009-02-12
ES2585777T3 (en) 2016-10-10
JP5111372B2 (en) 2013-01-09
WO2007025092A2 (en) 2007-03-01
US20120157496A1 (en) 2012-06-21
US20110028516A1 (en) 2011-02-03
US20130165480A1 (en) 2013-06-27
RU2444361C2 (en) 2012-03-10
EP2343048B1 (en) 2016-05-04
KR20080042144A (en) 2008-05-14

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